Clinical trials: Non-Muscle Invasive Bladder Cancer (NMIBC)
Non-Muscle Invasive Bladder Cancer, HER2
RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression
This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing.
- Trial name
- NCT05957757
- Testing
- RC48, Tislelizumab
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- RenJi Hospital
Carcinoma of Urinary Bladder, Superficial
Value of Immediate Post-operative Intravesical Epirubicin in Intermediate&High Risk Non Muscle Invasive Bladder Cancer
The aim of the study is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk non muscle invasive bladder cancer (NMIBC).
- Trial name
- NMIBCIVT (NCT02214602)
- Testing
- Epirubicin
- Where
- Egypt
- Volunteers
- 240 people
- Sponsor
- Mansoura University
Urinary Bladder Neoplasms, Carcinoma in Situ
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).
- Conditions
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT05014139
- Testing
- Enfortumab vedotin
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 37 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Carcinoma of Urinary Bladder, Superficial
Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC
In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare…
- Trial name
- OPTIMA (NCT01803295)
- Testing
- 40 mg MMC gel, Standard of care MMC mixed with water, 80 mg MMC gel
- Where
- 13 sites in Israel, Italy and 2 more
- Volunteers
- 80 people
- Sponsor
- UroGen Pharma Ltd.
Nonmuscle-invasive Bladder Cancer
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
This is a Phase II clinical study to evaluate the efficacy and safety of intravesical T3011 injection in participants with BCG-unresponsive high-risk NMIBC or BCG-exposed, chemotherapy-unresponsive intermediate/high-risk NMIBC.
- Trial name
- NCT06971614
- Testing
- T3011
- Where
- 9 sites in United States
- Volunteers
- 160 people
- Sponsor
- ImmVira Pharma Co. Ltd
Bladder Cancer
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
DURANCE is a two part, phase Ib/II, multi-centre study to assess the safety and activity of S-488210/S-488211 in combination with durvalumab, in patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- DURANCE (NCT04106115)
- Testing
- Durvalumab, S-488210/S-488211
- Where
- 7 sites in United Kingdom
- Volunteers
- 52 people
- Sponsor
- University College, London
Non-Muscle Invasive Bladder Cancer (NMIBC)
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment
A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.
- Trial name
- NMIBC (NCT03672240)
- Testing
- APL-1202
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Asieris Pharmaceutical Technologies Co., Ltd.
NMIBC
ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
This is a phase 1/2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus…
- Trial name
- NCT06800963
- Testing
- Intravesical Recombinant Mycobacterium (rMBCG)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- ImmunityBio, Inc.
Bladder Cancer
Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG
Background: Many cancers produce two particular proteins. The immune system can target these to attack the cancer. The PANVAC vaccine puts genes for these proteins inside a virus vaccine so the body sees the proteins as foreign…
- Trial name
- NCT02015104
- Testing
- BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG)), PANVAC
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Cancer Institute (NCI)
Non-muscle Invasive Bladder Cancer
Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients
To evaluate the clinical efficacy (median event-free survival) of APL-1202 in combination with Epirubicin hydrochloride versus Epirubicin hydrochloride alone in intermediate and high-risk chemo-refractory non-muscle invasive…
- Trial name
- ACCRUE (NCT04490993)
- Testing
- APL-1202 in combination with Epirubicin
- Where
- China
- Volunteers
- 359 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Urinary Bladder Neoplasms, BCG-Induced Cystitis
Early vs Delayed Intravesical Blad-Care During BCG Therapy
Intravesical Bacillus Calmette-Guérin (BCG) therapy is the standard adjuvant treatment for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC).
- Trial name
- PRO-GAG (NCT07495072)
- Testing
- Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™)
- Where
- South Korea
- Volunteers
- 56 people
- Sponsor
- BLAD-HYA Group
Non Muscle Invasive Bladder Cancer
Intravesical Ty21a for the Treatment of Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
Bladder cancer is the fourth and eighth most common malignancy among men and women, respectively. About 75% of bladder cancers are diagnosed as non muscle-invasive and according to specific tumor-stage and grade characteristics…
- Trial name
- NCT03421236
- Testing
- Ty21a
- Where
- Switzerland
- Volunteers
- 25 people
- Sponsor
- Patrice Jichlinski
NMIBC
A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with…
- Trial name
- NCT07424287
- Testing
- SHR-1501 for Injection, BCG for Injection, Epirubicin Hydrochloride for Injection
- Where
- 2 sites in China
- Volunteers
- 236 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Bladder Cancer
Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- NCT01373398
- Testing
- EO9(Apaziquone)
- Where
- 2 sites in South Korea
- Volunteers
- 11 people
- Sponsor
- Handok Inc.
Non-Muscle-invasive Bladder Cancer (NMIBC), Bacillus Calmette-Guerin (BCG) Cystitis
Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?
Compare the different supposed clinical treatment of side effects associated with intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs lornoxicam (NSAID)
- Conditions
- Non-Muscle-invasive Bladder Cancer (NMIBC), Bacillus Calmette-Guerin (BCG) Cystitis, Intra-vesical Instillation
- Trial name
- NCT03038321
- Testing
- sofenacin, Tavanic, Xefo
- Where
- Egypt
- Volunteers
- 150 people
- Sponsor
- Mansoura University
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07464145)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- 393 people
- Sponsor
- Relmada Therapeutics, Inc.
Non-Muscle-Invasive Bladder Cancer (NMIBC)
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer
This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression.
- Trial name
- NCT07646145
- Testing
- Disitamab Vedotin, Mitomycin C (MMC)
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanxi Province Cancer Hospital
Non-muscle Invasive Bladder Cancer
A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients
A multi-center, randomized, open-label, parallel-controlled Phase Ⅲ clinical trial to evaluate the clinical safety and efficacy of APL-1202 as a single-agent oral treatment versus intravesical instillation of Epirubicin…
- Trial name
- ASCERTAIN (NCT04736394)
- Testing
- APL-1202, Epirubicin Hydrochloride
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Intermediate and High-risk Non-muscle Invasive Bladder Cancer
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle…
- Trial name
- NCT06108492
- Testing
- SHR-2005
- Where
- China
- Volunteers
- 170 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Non-muscle-invasive Bladder Cancer
Intravesical BCG vs GEMDOCE in NMIBC
The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard…
- Trial name
- BRIDGE (NCT05538663)
- Testing
- Gemcitabine, Docetaxel, Bacillus Calmette Guerin
- Where
- 229 sites in United States
- Volunteers
- 870 people
- Sponsor
- ECOG-ACRIN Cancer Research Group